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Senior Design Quality Engineer II

Abbott Laboratories

This is a Contract position in Fort Collins, CO posted October 12, 2021.

Abbott is a global healthcare leader that helps people live more fully at all stages of life.

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Our 109,000 colleagues serve people in more than 160 countries.

Senior Design Quality Engineer II Pomona or, San Diego, or Remote Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis, and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health.

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life.

Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our location in Pomona or, San Diego, or Remote currently has an opportunity for a Senior Design Quality Engineer II .

This role will be Responsible for quality engineering activities that address product/process changes, product/process quality issues, and compliance issues.

This person will partner with operations for process improvement and continuous improvement initiatives and perform process audits of the operations areas.

This person may be involved in the development of new products and as such would support design control activities.

WHAT YOU’LL DO Lead quality assurance support in the design and development/on market support of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.

Create and maintain risk management files such as UMFMEA/DFMEA/PFMEA that identify Hazard Analysis Critical Control Points (HACCP) and are compliant with the requirements of ISO 14971:2019.

Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.

Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.

Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues.

Lead and support multiple projects, balancing priorities and resources to meet project and management expectations.

Review and approve proposed changes for on market products by performing risk assessments, providing guidance and support and assessing the adequacy of verifications and validations and DMR documents.

Review and approve verification and process validation, equipment qualification documents.

May coordinate activities of other personnel.

Lead process improvement projects Act as SME for key subsystems such as Design Control, Risk Management, Design Verification, Design Validation, Process Validation etc.

Act as a mentor to Quality Engineers/QA Staff Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities Carries out duties in compliance with established business policies Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies Perform other duties and projects as assigned EDUCATION AND EXPERIENCE YOU’LL BRING Required BS/BA degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry or Engineering Minimum of 9 years’ of experience in a quality role within the Biotechnology industry with 8 years of progressively responsible positions Minimum of 7 years hands-on risk management experience in maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.

Minimum of 7 years of Quality Assurance engineering experience (design controls, change control, on market quality engineering support and/or new project introduction) Minimum of 7 years of CAPA System, Non-conformity System and/or manufacturing process improvement experience.

Experience reviewing and approving process validations, equipment qualifications, required.

Experience reviewing and approving Device Master Record (DMR) documents required.

Preferred Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.

Experience acting as Quality Lead supporting new product development desired.

Experience with transferring a product from development to production desired.

Hands on Design Verification, Design Validation and Design History File (DHF) desired.

Process, QMS or Supplier auditing experience desired.

Experience with reagent, ELISA, HEIA manufacturing desired.

Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.

Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2019 standards.

Goal oriented, learns quickly, works in a collaborative manner with other departments.

Strong writing and verbal communication skills.

Knowledge of computers and software programs including Word, Excel, Access, Visio, MS Project, Minitab, PowerPoint and Agile.

Experience with root cause analysis, failure mode analysis, verification, and validation Statistical tools including basic statistical inference, graphical methods, regression.

Experience with process validations, design verification and design validation studies Knowledge of Quality System Regulations Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor Must be detail-orientated, self-motivated and available for flexible scheduling WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer: A fast-paced work environment where your safety is our priority Production areas that are clean, well-lit, and temperature-controlled Training and career development , with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including medical, dental, vision, wellness, and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and a history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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